Effect of Assisted Hatching on Vitrified Embryo Transfer Clinical Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- delivery rate
研究概览
简要总结
The objective of study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.
详细描述
The embryo implantation rate in assisted reproduction procedures is 20%, which leads to a low clinical pregnancy rate (35%), and even lower live birth rate (25%), per cycle started. Low embryo quality, poor endometrial receptivity, difficulties during the blastocyst hatching process are frequently denoted as the main reasons for the low implantation rate in humans.
The artificial rupture or thinning of the zona pellucida before embryo transfer-assisted hatching (AH)-has been proposed to foster spontaneous hatching and improve embryo implantation rates. Despite great effort, the clinical relevance of AH remains controversial and elusive.
There is a great importance of AH during frozen embryo cycles. Due to previous studies there is no precise answer about the value of AH performed on cryopreserved-thawed embryos. As far as is known, there is no clinical data to indicate the effects of AH on vitrified-warmed embryo transfer.
The objective of this prospective study is to assess the possible impact of assisted hatching on the implantation, pregnancy rate and delivery rate after transfer of vitrified-warmed human embryos.
Eligibility criteria: women age 18-42, cleavage-stage embryo transfer, less than seven IVF cycles with fresh embryo transfer, high quality embryos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women age 18-42,
- •cleavage-stage embryo transfer,
- •less than seven IVF cycles with fresh embryo transfer,
- •high quality embryos.
排除标准
- •out of 18-42 y.o.
- •blastocyst embryo transfer
- •more or equal to seven IVF cycles with fresh embryo transfer
- •low quality embryos
研究组 & 干预措施
No Assisted Hatching
No Assisted Hatching
Assisted Hatching
Mechanical Assisted Hatching - artificial rupture of the embryo external glycoprotein layer (Zona Pellucida) before embryo transfer.
干预措施: Mechanical Assisted Hatching (Device)
结局指标
主要结局
delivery rate
时间窗: 9 months
次要结局
- implantation rate(1 month)
- clinical pregnancy rate(2 months)
研究者
Volodarsky-Perel Alexander, MD
MD
Shaare Zedek Medical Center